Agenda eRA 2019

Day 1 - 22 May

subject to change

08:30 Registration and Networking Welcome Coffee

09:00 Opening Address and Welcome - Maximilian Munte and Martin Schmid, Managing Directors, EXTEDO

• We Listen to Your Feedback
• Results RIMS Survey
• Customer Success Project

09:30 Regulatory Telematics Panel -  Anjana Pindoria, Remco Munnik, Fakhredin Sayed Tabatabaei, Kevin Horan and Gary Wilson

10:00 Validating Artificial Intelligence in Regulatory - Klavs Esbjerg, Epista 

• What is Artificial Intelligence and how can it create value in Life Science: Software as (or in) a medical device, AI in a computer system (EDMS, ERP), Research, and more
• How is AI/machine learning related to data?
• Why is it critically important to keep data in control?
• What are the challenges, and solutions, when it comes to staying in control of data?
• What kind of problems do we have when we want to verify the results?

10:30 Networking Coffee Break

11:00 How Today's Telematics Will Shape the Way You Work Tomorrow. (SPOR, Target Operating Model, eAF, CESP and ePI) - Remco Munnik, ASPHALION 

• Overview of the Telematics Strategy
• Current status of ongoing programmes
• Impact on the Industry

11:30 How ePI (electronic Product Information) Will Impact Your Regulatory Working – Fakhredin Sayed Tabatabaei, Medicines Evaluation Board Netherlands 

• What is ePI: Product Information as a database?
• Downstream: How ePI will improve Patient Safety?
• Upstream: ePI and the facilitation of regulatory working

12:00 The Evolution of CESP – Kevin Horan, Bearing Point 

• The birth of CESP
• How CESP impacted the regulatory network
• The Future of CESP

12:15 Simplifying Your Controlled Vocabularies – Gary Wilson, CorrIT

• Approaching Master Data and Controlled Vocabulary Management
• Choosing the correct implementation style for your organization
• Establish strong data governance and drive data quality.

12:30 Introduction to the Interactive Sessions - Choose two of your favorite Barcamps

12:40 Networking Buffet Lunch

14:10 Submission Management in the Cloud

14:50 Submission Management in the Cloud

Moderated by Alexander Beck and Sven Pallarz, EXTEDO

14:10 Authorities and Industry – achieving mutual goals

14:50 Authorities and Industry – achieving mutual goals

Moderated by Schei Dattner, sales4u, Maren Müller and Michael Gessert, EXTEDO

14:10 Supporting the Collaboration between CRO and the Sponsor

14:50 Supporting the Collaboration between CRO and the Sponsor

Moderated by Kyle Stretch, EXTEDO and Remco Munnik, ASPHALION

14:10-17:30 Moderated by Inpharmatis

15:30 Networking Coffee Break

16:00 Regulatory Update for the EAEU Region - Konstantin Koshechkin, Scientific Center for Expertise of Medical Application Products, Ministry of Health, Russian Federation

• Regulation of digital submission for marketing approval of medicines in the Eurasian Economic Union
  • Legal regulation of the procedures in the Eurasian Economic Union
  • Market authorization and  medicines assessment rules in Eurasian Economic Union
  • Electronic submission of the dossier
  • Market authorization Procedure in the Russian Federation

16:30 Challenges and Best Practices on Asian Submissions - Simon Li, Molecular Science Center, Genetics Generation Advancement Corp. 

• The regulatory environment in Taiwan, a South East Asia Country
• What is the RA market strategy in Taiwan?
• How Taiwan RA concur the global submission challenges?

17:00 Optimization of Regulatory Data by Implementing RImanager at Kern Pharma - Marta Gascon Moya and Beatriz Domínguez Pérez, Kern Pharma

• The past: Decision for implementation of RIM solution
• The current: Challenges and achievements
• The future: Benefits and road ahead

Agenda Day 2 - 23 May